What is an impurity in Pharmaceutical?
An impurity in pharmaceuticals is classified as any component that is not the entity defined as the drug substance. In addition, for a drug product, any component that is not a formulation ingredient is considered an impurity. There are three different types of impurities in pharmaceuticals that API manufacturing companies must be wary of. Below, we provide a more in-depth look at each of these three types of impurities.
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